Multi-lumen endoscopic accessory and system

ABSTRACT

The embodiments of the present invention relate to an endoscopic system and accessories. In particular, the various embodiments relate to endoscopic systems in which an accessory comprises a multi-lumen device that is capable of quantitatively delivering at least a catheter, a balloon, and a needle to a site. The accessory is configured to allow for individual, independent control of its components. For example, in some embodiments, the needle and guidewire can be independently controlled. In addition, the needle may be retracted back into an inner lumen of the catheter body. Accordingly, during use, the accessory of the embodiments allows the user to maintain access to an incision site without having to exchange or remove accessories for various parts of the procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/848,545, filed on Aug. 2, 2010, entitled “MULTI-LUMEN ENDOSCOPICACCESSORY AND SYSTEM,” which claims priority to U.S. Provisional PatentApplication No. 61/230,175, filed on Jul. 31, 2009, entitled“COMBINATION ENDOSCOPIC ACCESSORY,” by Abhitabh Patil et al. both ofwhich are incorporated herein by reference in their entirety.

FIELD

The embodiments relate to endoscopic systems and methods, and moreparticularly, the embodiments relate to endoscopic accessories.

BACKGROUND

Endoscopy is a medical procedure in which an instrument is used toexamine and treat the interior of a patient's organ, usually through anatural orifice. For example, endoscopes are commonly used to examine ortreat a hollow organ or cavity of the body, such as the stomach.

Endoscopy procedures have become useful for treating, among otherthings, pseudocysts. Over 80,000 people are diagnosed with pancreatitisin the United States annually. The condition typically results in acuteupper abdominal pain and can be life threatening as the pancreas losesits endocrine and exocrine functions. In many cases, pancreatitisphysically manifests itself as a pseudocyst, which is a fibrouscollection of fluid formed atop the organ.

An effective treatment for the condition is through cyst drainage.Drainage of the cyst can be required if the cyst persists and or growsin size to be greater than five centimeters in diameter. Traditionally,pseudocysts have been treated surgically, requiring a large openincision through the stomach or with an endoscopic procedure.

Conventionally, endoscopic surgery was performed with a needle knife tomake an incision into the stomach. Unfortunately, this procedureincreased the risk for internal bleeding through the cutting of bloodvessels. As a result, typical procedures now use a balloon to dilate thetrack instead. This procedure is known as cystgastrostomy. This changehas resulted in endoscopic transmural drainage of pancreatic pseudocyststo become common as it makes use of a natural orifice, the mouth,instead of making an external incision through the stomach.

A cystgastrostomy is a minimally invasive procedure used to drain apancreatic cyst accessed endoscopically via the stomach wall. Afteridentifying a cyst via ultrasound, a first endoscopic instrument oraccessory is used to provide a hollow needle. The hollow needle isguided by an endoscope containing a thin guidewire and used to puncturethrough the stomach wall to access the pancreatic cyst. A puncturelocation is determined by an endoscopic ultrasound based on trying toavoid blood vessels and to prevent bleeding.

The current cystgastrostomy methods, however, require the full removalof the needle along the guidewire before the balloon can be positionedin the incision. The first instrument or accessory with the needle isremoved and the conventional procedure requires leaving the guidewire atthe site of the cyst.

Using a second endoscopic instrument or accessory, a surgical balloon isthen fed along the guidewire. The balloon is used to dilate theincision. The balloon is then deflated and also removed along theguidewire.

Fluid from the cyst drains into the stomach through a natural pressuregradient. Two to three pigtail stents may be inserted to facilitate thedrainage. The stents can be left in place for a few days and removed ata later time. The efficacy of the drainage is assessed during a post-opto ensure there is no infection from clogging of the stents.

As noted, the conventional methods and instruments require the fullremoval of the needle tip along the guidewire and the subsequentinsertion of a balloon along the same guidewire. This requires anexchange of endoscopic instruments or accessories. In this exchange,there exists a relatively high level of risk of guidewire dislocationfrom the pancreatic cyst access site. Such a loss of access is aconsiderable setback during this procedure because a gastroenterologistis then forced to either relocate the incision, or repeat the echoultrasound to determine another acceptable puncture location. Having tofind a new location only increases the risk of a hemorrhage.

Accordingly, it may be desirable to improve the conventional endoscopicprocedures, such as those mentioned above.

SUMMARY

In accordance with an embodiment of the present disclosure, anendoscopic accessory comprises: a multi-lumen catheter having a proximaland distal end; an inflatable balloon affixed to the distal end of thecatheter in fluid communication with a first lumen; and a hollow needlehoused within the multi-lumen catheter for independent movement relativeto the inflatable balloon; wherein the hollow needle is configured to beextended and retracted in conjunction with a guidewire at a desired sitewithin a patient.

In accordance with an embodiment of the present disclosure, anendoscopic system comprises: a multi-lumen catheter having a proximaland distal end, wherein the catheter comprises an inflatable balloonaffixed to the distal end of the catheter in fluid communication with afirst lumen, and a hollow needle housed within the multi-lumen catheterfor independent movement relative to the inflatable balloon; acontroller that is attachable to the multi-lumen catheter and having afirst portion configured to advance the catheter distally for placingthe inflatable balloon at the desired site and a second portionconfigured to extend or retract the hollow needle; and a guidewireconfigured to travel within the hollow needle, wherein the hollow needleis extended or retracted based on manipulation of the second portion ofthe controller and the guidewire is extended and retracted independentlyof the hollow needle at a desired site within a patient.

In accordance with an embodiment of the present disclosure, a method oftreating a patient with an accessory coupled to an endoscope isprovided. The method comprises: endoscopically introducing a multi-lumencatheter within a working channel of the endoscope, wherein the cathetercomprises an integral inflatable balloon and housing a hollow needlewithin a lumen; puncturing an organ wall, by manipulating a firstportion of the accessory to advance or retract the hollow needle via thecatheter, to create access to a desired site within the organ; advancinga guidewire within a lumen of the hollow needle to the desired site;retracting, by manipulating the first portion of the accessory, thehollow needle from the desired site, while maintaining the guidewire atthe desired site; advancing, by manipulating a second portion of theaccessory, the balloon to the desired site along the guidewire;inflating the balloon; and removing the multi-lumen catheter.

Additional features of the embodiments will be set forth in part in thedescription which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. Thefeatures of the embodiments can be realized and attained by means of theelements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate some embodiments of the inventionand together with the description, serve to explain the principles ofthe invention. In the FIGS.:

FIG. 1 illustrates an exemplary endoscopic procedure in which theembodiments may be employed.

FIG. 2 illustrates some exemplary process flows by the embodiments.

FIG. 3 shows an exemplary perspective view of a distal end of anembodiment of the present invention.

FIG. 4 shows an exemplary side view of a distal end of an embodiment ofthe present invention.

FIG. 5 shows an exemplary cross section B-B of a tube for an endoscopefor an embodiment of the present invention.

FIG. 6 shows an exemplary cross section A-A of a tube for an endoscopefor an embodiment of the present invention.

FIG. 7 shows a perspective view of the double lumen design of theembodiments.

FIG. 8 shows a portion of an endoscopic accessory for an embodiment ofthe present invention.

FIG. 9 shows a perspective view of an endoscopic accessory for anembodiment of the present invention.

FIGS. 10A-10C shows a side view of an endoscopic accessory for anembodiment of the present invention.

FIGS. 11A and 11B show an exemplary needle controller portion of anendoscopic accessory for an embodiment of the present invention.

FIGS. 12A and 12B show an exemplary catheter controller portion of anendoscopic accessory for an embodiment of the present invention.

FIG. 13 shows another perspective view of the endoscopic accessory foran embodiment of the present invention.

FIGS. 14A and 14B show perspective views of an endoscopic accessory foranother embodiment of the present invention.

FIG. 15 illustrates the operation of an embodiment of the presentinvention.

DESCRIPTION OF THE EMBODIMENTS

The embodiments of the present invention relate to an endoscopic systemand accessories. In particular, the various embodiments relate toendoscopic systems in which an accessory comprises a multi-lumen devicethat is capable of quantitatively delivering at least a catheter, aballoon, and a needle to a site. The accessory is configured to allowfor individual, independent control of its components. For example, insome embodiments, the needle and guidewire can be independentlycontrolled. In addition, the needle may be retracted back into an innerlumen of the catheter body. Accordingly, during use, the accessory ofthe embodiments allows the user to maintain access to an incision sitewithout having to exchange or remove accessories for various parts ofthe procedure.

For purposes of illustration, the embodiments are described for use asan endoscopic accessory for drainage of pancreatic cysts. It will beapparent to those of skill in the art that the accessory is readilyadaptable for other procedures including other endoscopy procedures aswell as laparoscopy procedures. The embodiments may be used withvirtually any type of minimally invasive procedure.

Accordingly, all dimensional measurements disclosed here are forexemplary purposes only and can be changed, as needed depending upon thetype of procedure and the relative area within which the device will beused. Furthermore, all dimensions disclosed herein are approximate,although it is noted that this is a precision instrument and relativelytight controls may be employed to ensure proper operation.

To assist in explaining the embodiments, the present disclosuredescribes a procedure involving drainage of pancreatic cysts. For such aprocedure, the endoscopic working channel may have a diameter of about3.1 mm. Accordingly, the accessory of the embodiments is configured foruse within this diameter. However, as the diameter of the workingchannel varies so can the dimensions of the accessory.

The endoscopic accessory described herein comprises a multi-lumencatheter, balloon, and hollow needle. In some embodiments, the accessoryis adapted for use in cystgastrostomy for facilitating the drainage ofpancreatic cysts. Additional components may also be used to enhance theusability of the device. In particular, a connection valve for splittingthe multi-lumen at the proximal end for individual control of each lumenmay be used. An extension mechanism for controllably advancing theballoon may also be provided.

Although any suitable catheter design may be employed, a catheter havingmultiple lumens is described. The present disclosure will generallyrefer to the accessory and catheter as having a proximal end nearest theendoscope and a distal end nearest the procedure site.

In general, the procedure for cystgastrostomy may comprise having thehollow needle pass through and within an inner lumen (the needle lumen).In turn, the guidewire passes through and within the hollow needle. Theballoon is affixed to the exterior wall of the distal end of the innerlumen and at the balloon's proximal end to the exterior wall of theouter lumen, i.e. the external catheter wall. In this manner, theinternal volume of the balloon is in fluid communication with the outerlumen (the fluid lumen), through which a filling medium is passed tofill the balloon and removed to deflate the balloon.

The filling medium is chosen according to the procedure and itslocation. The medium should be chosen so as to be relatively safe, inthe event the balloon should inadvertently rupture and the fillingmedium be released. Suitable filling media include air, other gas,sterile water, sterile saline, and the like. For example, for apancreatic cystgastrostomy, sterile water or saline may be employed asthe filling medium, since any leakage will occur in the stomach, whichwill readily accept the liquid.

The hollow needle can be any type of hollow needle suited to thespecific procedure. The hollow needle is sized for ease of removalthrough the inner lumen while being able to make an appropriately sizedincision. As will be recognized by those of skill in the art, the needlemay have a tip that is sharp enough for piercing. For example, theneedle may be sufficiently sharp to pierce the stomach lining for use ina pancreatic cystgastrostomy, the stomach lining. The piercingfacilitates access to the pancreatic cyst beyond the stomach wall.

A guidewire may be provided for advancing through the hollow needle. Theguidewire is affixed to the treatment site (e.g. cyst) so that it may beused to guide placement of further articles, such as stents, at thetreatment site. Any suitable guidewire may be used.

In accordance with some embodiments of the invention, once the incisionis made, the balloon catheter can be moved distally into the incisionmade by the needle and then inflated. This can be accomplished by meansof an extension mechanism designed for controllably and preciselyadvancing the balloon the desired depth into the incision.

The embodiments thus have certain advantages over known procedures andinstruments. For example, current procedures and instruments must relyalmost solely on the skill of the surgeon, who operates largely by“feel.” In contrast, employing the extension mechanism of theembodiments allows for accurate and informed advancement of the balloon.

In the embodiments, the distance from the needle at the time of punctureto the balloon can be quantitatively and continuously tracked. Thus, thesurgeon can know precisely how far the balloon will need to be advancedto be in appropriate position to expand the incision. In many cases, theincision will be centered along the length of the balloon, although thisis not necessary.

In some embodiments, the multi-lumen catheter exits the proximal end ofthe working channel of the endoscope and runs through an extensionmechanism or connection valve. The extension mechanism can be atelescoping device designed to provide added control to thegastroenterologist while pushing the entire catheter into the cyst.

The connection valve is designed to separate the multiple lumens forindividual control by the surgeon. The extension mechanism andconnection valve may be integrated into a single component in some ofthe embodiments.

The extension mechanism may comprise an inner and an outer cylinder in aslidable arrangement with each other. In some embodiments, the innercylinder may have a diameter of about 15.5 mm and connects to theworking channel port using a female connection. A channel of about 3.0mm may then provided to be the same size as the working channel and ispreserved through the cylinder.

A hollow outer cylinder, with an outer diameter (“OD”) of about 20 mmand an inner diameter (“ID”) of about 16 mm, may accept the innercylinder. Mating projections and grooves may be provided on the outersurface of the inner cylinder and the inner surface of the outercylinder to minimize or prevent axial rotation.

In some embodiments, the inner cylinder has a length of about 10 cm(i.e., the outer can have an equivalent channel) allowing an extensionof about 8 cm. Calibrations on the inner cylinder along with a viewingport, such as a circular cutout on the outer cylinder, can allow for thephysician to have quantitative control on the degree of insertion of theentire catheter into the incision site. A lock ring can also be providedto secure the position with the tightening of it to the inner cylinderusing a bolt.

The proximal portion of the outer cylinder can serve as or be adaptedfor connection to a connection valve splitting the needle and fluidlumen of the catheter. The valve can be cast out of molten plasticaround the proximal tip of the lumen. The needle channel can thuscontinue out through the proximal end and a fluid channel can run out ofthe side of the valve (e.g., about 2 cm from the end) for communicationwith a fluid source.

In some embodiments, the splitting of the lumen channels can take placeover a distance, such as about 6 cm. Additional features of the valveallow for the connection of existing controllers. For example, at thetop of the valve (e.g., around the needle channel), a reproduced workingchannel port can allow an existing controller to be secured.

A fitting, such as a luer lock connection, can be used extending fromthe fluid channel to allow fluid to be pumped through the channel usingfluid source controller. For example, water can be pumped and removedthrough the fluid channel via a balloon dilator. Once in position, theballoon can be inflated to enlarge the incision to facilitate placementof one or more stents or other instruments.

Once the incision is enlarged, the balloon is deflated, and the catheterremoved along the guidewire. The guidewire is left in place for furthertreatment, such as insertion of stents for facilitating drainage of thecyst. Because a floating (concentric) inner lumen is unnecessary, a moretraditional and available semi-circle double lumen or other double lumenconstruction can be used.

A catheter is provided with multiple lumens each defined by a catheterwall. A first lumen is provided for housing the hollow needle formovement therein. The second lumen is used or adding and removing fillermedium to inflate and deflate the balloon respectively. The balloonvolume is again in fluid operation with the second lumen.

The proximal end of the balloon may be affixed to the outer wall of thecatheter, and affixed at its distal end such that filler medium leavesthe second lumen and enters the balloon volume thereby inflating theballoon. This embodiment can provide stiffness and improved durabilitydue to increased wall thickness. The balloon may be attached via a weld.The water channel of the lumen seals off at the distal end and makesdilation possible while keeping the needle channel intact.

Reference will now be made in detail to the present embodiments,examples of which are illustrated in the accompanying drawings. Whereverpossible, the same reference numbers will be used throughout thedrawings to refer to the same or like parts.

FIG. 1 illustrates an exemplary endoscopic system and procedure in whichthe embodiments may be employed. In particular, an endoscopic procedurefor treating a pancreatic pseudocyst is shown to illustrate theprinciples of the embodiments.

As shown, a patient 100 is being treated with an endoscope 102. Theendoscope 102 provides a working channel 104. At the proximal end, anaccessory 106 may then be attached to the endoscope 102 in order toaccess the working channel 104. During a procedure, a guidewire 108 maybe fed through the accessory 106 to access the site at the distal end.At the distal end, the accessory 106 may provide a needle tip 108 thatcan pierce the patient's stomach wall and access the pancreatic cyst 110via the patient's abdominal cavity.

FIG. 2 illustrates some exemplary process flows by the embodiments thatmay be employed to treat a pancreatic cyst or pseudo cyst. As shown, twoprocesses may be used by the embodiments to treat a pancreatic cyst orpseudo cyst. For purposes of illustration, the process flows of FIG. 2are described with reference to accessing the cyst near the stomachthrough a patient's abdominal cavity.

At phase 200, the cyst 110 is identified. For example, the cyst 110 maybe identified using an ultrasound image or other suitable diagnosticprocedure.

At phase 202, a user, such as a surgeon or gastroenterologist, maydetermine and select a desired or prime puncture in the patient'sstomach. The site may be determined and selected based on a variety ofcriteria, such as avoidance of blood vessels and likelihood of bleeding,as well as the location of the cyst.

In a first embodiment, at phase 204, the user may utilize the accessory106 to insert a hollow needle tip into the stomach wall and puncture thecyst 110 through the wall of the patient's stomach.

Next, at phase 206, the user may insert a guidewire 108 through theendoscope 102 into the cyst 110. In phase 208, the hollow needle is thenremoved along the guidewire 108.

In phase 210, a balloon (not shown in FIG. 1) is fed along the guidewire108 into the incision previously made by the hollow needle tip. In phase212, the user then inflates the balloon to dilate the incision. Forexample, the balloon may be inflated with a suitable medium, such assaline.

In phase 214, the user then deflates the balloon and removes it from theincision site. In phase 216, the user then may place one or more pigtailstents (not shown in FIG. 1) into the dilated opening of the stomachwall. The pigtail stents may be used, for example, to maintain theopening in the stomach and allow the cyst to drain over time.

Alternatively to phases 204 to 214, another embodiment of the presentdisclosure may utilize a shorter procedure. For example, in phase 218, auser, such as a surgeon, may insert a hollow needle into the patient'sstomach wall and puncture the wall to access the cyst 110.

In phase 220, the user may then insert the catheter and balloon andinflate the balloon to dilate the incision made previous by the needle.In phase 222, the user then inserts a guidewire 108 through the hollowneedle into the cyst 110.

In phase 224, the user then allows the balloon to deflate and retractsthe catheter from the site. As will be recognized and further describedin the present disclosure, this procedure allows the user to maintainconsistent access to the site without changing endoscopy instruments oraccessories.

FIG. 3 shows an exemplary perspective view of a distal end 300 of anembodiment of the present invention. FIG. 4 shows an exemplary side viewof the distal end 300.

As shown, at the distal end 300, a hollow needle shaft 304 terminates ata hollow needle tip 302.

Although the characteristics of the entire endoscopic accessory 106 andits component parts can vary depending upon its intended use, for apancreatic gastrostomy, the hollow needle may be a 19 gauge needle (orother suitable gauge), have a 0-3.149 inch needle extension, and able tohouse a 0.035 inch guidewire 108. In addition, sheath of the hollowneedle sheath may be approximately 140 cm in length and may have aspecimen notch of about 20 mm.

In one embodiment, the needle is made of medical grade stainless steel(OCr₁₉Ni₉) that has a high tensile strength to prevent breakage duringpuncture. The needle may also be relatively ductile.

The needle shaft 304 may be contained within an inner lumen (or needlelumen or needle channel). As shown, at distal end 300, the needle shaft304 may exit the inner lumen at neck 306 to puncture and access adesired site in patient 100.

A balloon 310 may also be provided at distal end 300. The balloon 310may be about 0.315-0.472 inch in diameter for inflation (8-12 mm, 24-36French) and support inflation pressures between about 3 and 9 ATM. Inthe embodiments, the balloon 310 is sized depending upon its intendeduse. For about, in one embodiment the balloon 310 can be about 4 cm inlength. In other embodiments, the balloon 310 may be about 8 cm inlength. The balloon 310 may also have a radio-opaque distal end to makedistinguishable during fluoroscopy. The balloon 310 may a length thatcan stretch along the tract of a puncture, for example, in the stomachwall to cyst 110 (such as, approximately 0.275 inches-0.394 inches).

The balloon 310 may be constructed from PEBAX, or other biocompatiblepolymer (biocompatible polymer composed of rigid polyamide blocks andsoft polyether blocks). In general, any high strength, resilientmaterial with great elasticity can serve as a material for balloon 310.The material may also be a soft material for easy machining andmaneuverability through the puncture site. Furthermore, a biocompatiblesurgical lubricant can be used to coat balloon 310 to reduce frictionduring puncture or the procedure.

Of note, the inner or needle lumen extends slightly beyond the outerlumen at the distal end 300. Thus, the balloon 310 may be in fluidcommunication to the fluid lumen at the proximal end of endoscope 106and to the needle lumen at the distal end 300. The result of this is aseal that allows water to flow into the balloon 310, but not out of theother side.

The balloon 310 may be heat welded (e.g., with a total length of about4-8 mm) onto the extended needle channel (1.00 mm from the tip) at thedistal end and onto the outer edge of the lumen at the proximal end. Theresult of this is a seal that allows water to flow into the balloon butnot out of the other side. The use non-light weight walls andnon-floating lumen (despite the extension of the needle channel) alsomay provide sufficient axial rigidity to push the catheter into theincision site. The distal tip of the exposed lumen may have a gradientslope allowing for a smooth transition of increasing diameters. Also,the balloon 310 may be trained to deflate into a circular shape with adiameter of less than 3.1 mm.

For example, as shown, the balloon 310 may be attached to the outer wallof the inner lumen at 308. In some embodiments, the balloon 310 iswelded to the outer wall of the inner lumen at 308. Of course, otherattachment means, such as glue, may be used to bond the balloon 310.

The balloon 310 is also attached to the outer wall of an outer lumen 314(or catheter fill lumen or water fill lumen). As shown, the balloon 310may be welded, glued, etc. to the outer wall of the outer lumen 314along a length 312. Accordingly, by being attached to the outer walls ofboth the inner lumen and outer lumens, the balloon 310 may be in fluidcommunication with the accessory 106 at the proximal end of theendoscope 102.

FIGS. 5 and 6 are provided to show different exemplary cross sectionsthat may be employed along the length of the catheter from endoscope106. As will be further described, the embodiments may employ a“floating” concentric cross section design (e.g., cross section B-Bshown in FIG. 5) and an “attached” cross section design (e.g., crosssection A-A shown in FIG. 6).

As shown in FIG. 3, the cross section B-B may be employed distallybeyond the balloon 310. This design may be employed to ensure maximumfreedom of motion of the components controlled by accessory 106 andclearances. In other locations, such as proximally before the balloon310, the cross section A-A may be employed to provide enhanced rigidity,e.g., to aid in puncture strength and to minimize crumpling of theballoon 310 during puncture. In one embodiment, the length of theendoscope proximally before the balloon 310 employs cross section A-A.In other embodiments, the cross section B-B is employed at discretepoints along the length of the catheter. These discrete points may be atregular intervals or spaced apart depending upon various factors, suchas bending radius, etc. The cross section B-B may be constructed by heatbonding or welding the inner catheter 504 to the inner wall of the outercatheter 502.

FIG. 5 shows an exemplary cross section B-B of a tube for an endoscopefor an embodiment of the present invention. As shown, the embodimentsmay employ a multi-lumen design. For example, in FIG. 5, a double lumenembodiment is shown. The double lumen embodiment shown provides a pathto pull the needle out (the inner lumen or needle lumen) and providing amethod to inflate the balloon (the water fill catheter). In general, theendoscope tube 500 may house a first (or water fill) catheter 502. Waterfill catheter 502 provides an outer lumen for water fill of the balloon310. In addition, catheter 502, within its lumen, may house an inner (orneedle) catheter 504.

In the embodiment shown, the needle lumen has a diameter of 1.57 mm inorder to house the 19 gauge needle. The fluid lumen, when round, may beabout 2.9 mm in diameter, or otherwise has adequate space to allow water(or other filling media) to flow through for inflation of the balloon.In addition, this 2.9 mm diameter allows for easy access into the 3.1 mmendoscope catheter. Both catheters 502 and 504 may be constructed fromPTFE/Teflon tubing. Other embodiments may incorporate PEBAX tubing. Theuse of a double lumen can also result in a more rigid catheter that isable to more easily push into the incision site. The inside catheteradds sufficient stiffness to the design while still keeping itmaneuverable.

FIG. 6 shows an exemplary cross section A-A of a tube for an endoscopefor an embodiment of the present invention. As shown, the inner catheter504 may be attached or bonded to the inner wall of the outer catheter502 at location 600. As noted above, this attachment of the catheters502 and 504 may be employed to improve the rigidity of the catheteroverall and to avoid excessive movement of the catheters 502 and 504relative to each other.

FIG. 7 shows a perspective view of the double lumen design of theembodiments. As shown, the endoscope catheter 500 may house a water fillcatheter 502 within its lumen. In addition, needle catheter 504 may behoused within the water fill catheter 504 to provide an inner (orneedle) lumen.

FIG. 8 shows a portion of an endoscopic accessory for an embodiment ofthe present invention. As shown, the endoscope accessory 106 maycomprise at its front end a catheter (or balloon) controller 800, alocking mechanism 802, and an attachment port 804. Catheter controller800 is described further below. Attachment port 804 and lockingmechanism 802 provides a fitting (such as a luer lock) and sealingmechanism to secure accessory 106 to the working channel 104 of theendoscope 102.

FIG. 9 shows a perspective view of an endoscopic accessory 106 for anembodiment of the present invention. FIGS. 10A-C show a side view of anendoscopic accessory for an embodiment of the present invention.

As shown, the accessory 106 may comprise multiple controllers. Thismulti-controller design allows for procedures, such as a pancreaticcystgastrostomy, to be performed without having to exchange or usemultiple accessories and instruments.

For example, as shown, the accessory 106 may comprise a cathetercontroller 800 at its front end a needle controller 900 at its back end.In the embodiment shown, the accessory 106 employs a sliding mechanismthat allows the user to selectively control the needle and balloon atdifferent times both independently and without having to changeaccessories.

As also shown, the accessory 106 may comprise locking nuts 902 toselectably secure controllers 800 and 900 at a specific location alongits slidable length. Although a sliding mechanism is shown, theembodiments may employ other types of mechanical motion, such as arotary or screw based motion.

Accessory 106 further comprises ports 904 and 908. Port 904 may beprovided to allow for media, such as water, saline, etc., to be injectedinto the balloon 310 at the distal end 300. Port 908 provides an entry,for example, of guidewire 108 and a needle (not shown) by the user.

Separator channel tube 906 provides for mechanical travel for thecontrollers 800 and 900. In addition, the separator tube 906 may providea connector valve (not shown). To ensure that each lumen functionsrespectively, a connector valve splits the double lumen design intorespective components. The valve has one section that connects to thefluid lumen and another that connects to the needle lumen.

For the purposes of the drainage of a pancreatic pseudocyst, the fluidlumen can be connected to a water gun for example at port 904, while theneedle lumen will be connected to controller 900 that allows for minutecontrol over the puncturing needle. The distal end of the valve is maybe large enough to securely fasten onto the double lumen. In oneembodiment, the entire length of the valve is 60 mm with an outerdiameter of 25 mm and an inner diameter of 2.8 mm.

FIGS. 11A and 11B show an exemplary needle controller portion 900 of anendoscopic accessory for an embodiment of the present invention. Asshown, the needle controller 900 may comprise a ruler 1100 and a lockingmechanism 1102.

Ruler 1100 provides the user a visual indication of the amount of travelthat has been used for moving the needle. The ruler 1100 may providevarious units of measure, such as inches, cm, mm, etc., depending on theprocedure and amount of travel desired. In addition, ruler 1100 may bemarked to indicate various thresholds, such as minimum travel, maximumsuggested travel, and the like.

Locking mechanism 1102 provides a port for securing the needlecontroller 900, if desired. For example, mechanism 1102 may be designedto accommodate a bolt, such as the locking bolt 902 shown in FIG. 9. Asalso shown in FIG. 11B, the needle controller 900 may comprise a slot1104 to accommodate port 904 (as shown in FIG. 9).

The exemplary characteristics of the needle controller may include:

A push/pull extension mechanism to control needle extension;

Allow for extension of about 4 inches;

Handgrips for ease of control;

A first cylinder: 15 mm

A second cylinder: 12 mm

A T Handle: 65 mm width, 10 mm height and 5 mm depth

A base Handle: 20.05 mm width 6 cm length

The needle controller may be calibrated to ensure accurate movement ofthe needle;

A guidewire access point 908 of about 1.4 mm

A calibrated movement ruler in cm reflecting needle extension

The tip of the controller connects the extended inner lumen

Internal Components of Needle Controller may comprise:

A metal casing (surrounding proximal needle sheath): 1.58 mm

FIGS. 12A and 12B show an exemplary catheter controller portion 800 foran embodiment of the present invention. As shown, the cathetercontroller 800 may comprise a ruler 1200, an alignment slot 1202, alocking mechanism 1204, and a fitting 1206.

Ruler 1200 provides the user a visual indication of the amount of travelthat has been used for moving the catheter having balloon 310. The ruler1200 may provide various units of measure, such as inches, cm, mm, etc.,depending on the procedure and amount of travel desired. In addition,ruler 1200 may be marked to indicate various thresholds, such as minimumtravel, maximum suggested travel, and the like.

Alignment slot 1202 provides a slot to maintain the radial alignment ofthe controller 800 during its use. Of note, needle controller 900 mayalso comprise a slot that is similar to slot 1202.

Locking mechanism 1204 provides a port for securing the needlecontroller 900, if desired. For example, mechanism 1204 may be designedto accommodate a bolt, such as the locking bolt 902 shown in FIG. 9.

Fitting 1206 provides the necessary physical structure to couple theaccessory 106 to the working channel 104. Such fittings are well knownto those skilled in the art.

FIG. 13 is provided to show another perspective view of the endoscopicaccessory for an embodiment of the present invention. As noted, thedistal end and proximal ends of the device will be connected by a doublelumen, the characteristics of which may include: a needle lumen withdimension of 1.575 mm which houses hollow needle; a fluid lumen withabout a 2.9 mm diameter that serves as a water channel, or volumesuitable for proper inflation; a wall thickness of about 0.127-0.200 mmor smaller as desired.

Below are some exemplary characteristics of the catheter-controllerconnection valve. The valve splits the distal catheter tubing into twoseparate tubes to be sent to distinct controllers. A slot insertion ofouter lumen (fluid lumen) to prevent water leakage. Two proximalchannels are provided: one for water travel, one for needle control.

In one embodiment, the multi-lumen design allows for two functions:providing a path to pull the needle out and providing a method toinflate the balloon. The multi-lumen has a total diameter of 2.9 mm,allowing for sufficient clearance to maneuver through a 3.1 mm workingchannel of an endoscope. A cross section of the lumen reveals dualchannels. A circular channel, sharing a wall with the outer edge of thelumen, has a diameter of 1.575 mm in order to house the 19 gauge needle(and potentially any additional needle sleeves). An exaggeratedsemicircular channel makes up the remaining portion of the lumen(separated by the outer wall of the lumen and the inner wall of theneedle channel). All walls of the lumen have a uniform thickness of0.200 mm, creating a large enough water channel to allow for sufficientflow. The needle channel can be advanced such that it extends past thewater channel a sufficient length, for example, to attach the balloon310.

FIGS. 14A and 14B show perspective views of an endoscopic accessory foranother embodiment of the present invention. In the embodiment shown,the endoscopic accessory 106 may employ a locking bar mechanism. Asshown, the accessory 106 may comprise a catheter controller 1404 and aneedle controller 1402. The controllers 1400 and 1402 may be connectedtogether via a separator channel tube 1404.

In this embodiment, the tube 1404 comprises a locking bar 1406. Forexample, during operation, the user may rotate either controllers 1400or 1402 such that guide slots 1408 and 1410, respectively align withlocking bar 1406. When not aligned, the controllers 1400 and 1402 areheld in place and prevented from moving.

In some embodiments, the locking bar 1406 is configured to allow onlyone controller at a time to move. In other embodiments, the locking bar1406 allows both controllers to move simultaneously when aligned.

FIG. 15 illustrates the operation of an embodiment of the presentinvention. In stage 1500, the user has selected a desired site and hasbegun placing the needle via the endoscope 102 through working channel104. The operation of accessory 106 may now be explained with referenceto stages 1502 through 1514. As can be recognized, the embodiments allowthe procedure to be performed with a single accessory and without theneed of removing or exchanging any accessories, if desired. Forpurposes, of illustration, FIG. 15 shows the procedure at both thedistal and proximal end.

In stage 1502, the user inserts the needle into the puncture site byselectively moving needle controller 900 forward. As noted, the user mayrely upon ruler 1100 as a guide to determine how far to insert theneedle.

In stage 1504, the user may feed a guidewire 108 through entry port 908.The guidewire 108 will travel through the inner lumen of needle catheter504. At the site at the distal end, the user may then manipulate theguidewire 108 to secure it, for example, to the cyst.

In stage 1506, the user may then withdraw the needle by pulling back onthe needle controller 900. Alternatively, the user may simply pull onaccessory 106 to withdraw the needle.

In stage 1508, the user may then insert the balloon catheter 502 bysliding the catheter controller 800 forward. Again, the user may utilizeruler 1200 as an aid to quantitatively determine how far to insert theballoon catheter.

In stage 1510, the user injects a fill media, for example, using anAlliance II water gun at port 904 to inflate the balloon 310. As shown,the balloon 310 inflates and dilates the puncture site at the distalend.

In stage 1512, the user then withdraws or drains the fill media from theballoon 310 out from port 904. At the distal end, the balloon 310deflates.

In stage 1514, the user may then withdraw the balloon catheter 502 byeither pulling on controller 800 or pulling accessory 106 at theproximal end. Optionally, the user may then insert other devices, suchas stents, to maintain the dilated puncture site.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. An endoscopic accessory comprising: a multi-lumen catheter having aproximal and distal end; an inflatable balloon affixed to the distal endof the catheter in fluid communication with a first lumen; and a hollowneedle housed within the multi-lumen catheter for independent movementrelative to the inflatable balloon based on manipulation of a controllerof the accessory, wherein the controller comprises an inner cylinder anda plurality of outer cylinders adapted for independent movement relativeto each other, and wherein the hollow needle is configured to beextended and retracted by manipulating the controller in conjunctionwith a guidewire configured to travel within the hollow needle at adesired site within a patient.
 2. The accessory of claim 1, wherein theinflatable balloon is configured to wrap around the catheter in itsdeflated state.
 3. The accessory of claim 1, wherein the hollow needleranges from about a 19 gauge to a 22 gauge.
 4. The accessory of claim 1,wherein the hollow needle is configured to extend about 8 cm from thedistal end.
 5. The accessory of claim 1, wherein the guidewire comprisesa diameter of approximately 0.035 inches.
 6. The accessory of claim 1,wherein the inflatable balloon is radio-opaque.
 7. The accessory ofclaim 1, wherein the inflatable balloon is molded.
 8. An endoscopicsystem comprising: a multi-lumen catheter having a proximal and distalend, wherein the catheter comprises an inflatable balloon affixed to thedistal end of the catheter in fluid communication with a first lumen,and a hollow needle housed within the multi-lumen catheter forindependent movement relative to the inflatable balloon; a controller,comprising an inner cylinder and a plurality of outer cylinders adaptedfor independent movement relative to each other, that is attachable tothe multi-lumen catheter and having a first outer cylinder configured toadvance the catheter distally for placing the inflatable balloon at thedesired site and a second outer cylinder configured to extend or retractthe hollow needle; and a guidewire configured to travel within thehollow needle, wherein the hollow needle is extended or retracted basedon manipulation of the second outer cylinder of the controller and theguidewire is extended and retracted independently of the hollow needleat a desired site within a patient.
 9. The system of claim 8, whereinthe outermost cylinder is connectable to a working channel of anendoscope.
 10. The system of claim 8, wherein the outermost cylinder isconnectable to the proximate end of the multi-lumen catheter.
 11. Thesystem of claim 8, wherein longitudinal movement of the first outercylinder with respect to the inner cylinder causes advancement orretraction of the multi-lumen catheter within the working channel of theendoscope.
 12. The system of claim 11, wherein at least one of theplurality of outer cylinders of the controller comprises a set ofmarkings indicating a distance of advancement or retraction.
 13. Thesystem of claim 8, wherein the controller comprises a separator valvethat selectably connects lumens of the multi-lumen catheter to aseparate controller.
 14. The system of claim 8, wherein the controllercomprises a port that is in fluid communication with the balloon.
 15. Amethod of treating a patient with an accessory coupled to an endoscope,said method comprising: endoscopically introducing a multi-lumencatheter within a working channel of the endoscope, wherein the cathetercomprises an integral inflatable balloon and housing a hollow needlewithin a lumen and wherein the accessory comprises a controller that isattachable to the multi-lumen catheter and having an inner cylinder anda plurality of outer cylinders adapted for independent movement relativeto each other, wherein a first outer cylinder of the accessory isconfigured to advance the catheter distally for placing the inflatableballoon at the desired site and a second outer cylinder of the accessoryis configured to extend or retract the hollow needle; puncturing anorgan wall, by manipulating a first outer cylinder of the accessory toadvance or retract the hollow needle via the catheter, to create accessto a desired site within the organ; advancing a guidewire within a lumenof the hollow needle to the desired site; retracting, by manipulatingthe first outer cylinder of the accessory, the hollow needle from thedesired site, while maintaining the guidewire at the desired site;advancing, by manipulating a second outer cylinder of the accessory, theballoon to the desired site along the guidewire; inflating the balloon;and removing the multi-lumen catheter.
 16. The method of claim 15,wherein puncturing the organ wall comprises puncturing a stomach wallvia an abdominal cavity of a patient.
 17. The method of claim 15,wherein puncturing the organ wall to create access to the desired sitewithin the organ comprises puncturing the organ wall to create access toa cyst within the organ.
 18. The method of claim 15, further comprisingadvancing a stent along the guidewire after removing the multi-lumencatheter.
 19. The method of claim 15, wherein the accessory comprises acontroller having a set of markings that indicate a distance ofadvancement or retraction of the hollow needle and a distance ofadvancement or retraction of the catheter.